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Optimizing VELCADE® (bortezomib) Therapy for Advanced Practitioners

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Indications and Important Safety Information for
VELCADE® (bortezomib)

INDICATIONS
VELCADE (bortezomib) is indicated for the treatment of patients with multiple myeloma. VELCADE is indicated for the treatment of patients with mantle cell lymphoma who have received at least 1 prior therapy.

CONTRAINDICATIONS
VELCADE (bortezomib) is contraindicated in patients with hypersensitivity to bortezomib, boron, or mannitol. VELCADE is contraindicated for intrathecal administration.

WARNINGS AND PRECAUTIONS
VELCADE (bortezomib) is for subcutaneous or intravenous (IV) administration only. Because each route of administration has a different reconstituted concentration, caution should be used when calculating the volume to be administered. Complete blood counts should be monitored frequently during treatment with VELCADE.

Peripheral Neuropathy, including severe cases, may occur. Patients should be monitored for symptoms and managed with dose modification or discontinuation. Patients with preexisting symptoms may experience worsening peripheral neuropathy (including ≥ grade 3). Starting with VELCADE (bortezomib) subcutaneously may be considered for patients who either have preexisting or are at high risk for peripheral neuropathy.

Hypotension can occur. Caution should be used when treating patients receiving antihypertensives, those with a history of syncope, and those who are dehydrated.

Cardiac Disorders including acute development or exacerbation of congestive heart failure and new onset of decreased left ventricular ejection fraction, have been reported. Isolated cases of QT-interval prolongation have been reported. Patients with risk factors for, or existing, heart disease should be closely monitored.

Pulmonary Disorders, some fatal—including pneumonitis, interstitial pneumonia, lung infiltration, and acute respiratory distress syndrome (ARDS)—have been reported. Pulmonary hypertension in the absence of left heart failure or significant pulmonary disease has also been reported.

Gastrointestinal Adverse Events including nausea, diarrhea, constipation, and vomiting, have occurred and may require use of antiemetic and antidiarrheal medications or fluid replacement.

Thrombocytopenia/Neutropenia can occur—manage with dose and/or schedule modifications. Platelets should be monitored prior to each dose of VELCADE (bortezomib). There have been reports of gastrointestinal and intracerebral hemorrhage. Transfusions may be considered.

Patients With Hepatic Impairment: Exposure to VELCADE (bortezomib) is increased in patients with moderate or severe hepatic impairment. Start these patients at a lower dose of VELCADE and adjust after cycle 1, depending on tolerability.

Patients With Diabetes: Hypoglycemia and hyperglycemia have been reported with use of VELCADE (bortezomib). Patients may require close monitoring and adjustment of the antidiabetic medications.

Tumor Lysis Syndrome, Reversible Posterior Leukoencephalopathy Syndrome (RPLS) and Acute Hepatic Failure have been reported.

Pregnancy and Nursing: Women should avoid breastfeeding or becoming pregnant while on VELCADE (bortezomib).

DRUG INTERACTIONS:
Closely monitor patients receiving VELCADE (bortezomib) in combination with strong CYP3A4 inhibitors. Concomitant use of strong CYP3A4 inducers is not recommended.

ADVERSE REACTIONS
Previously Untreated Multiple Myeloma (MM): In the phase 3 study of VELCADE (bortezomib) administered IV with melphalan and prednisone (MP) vs MP alone, the most commonly reported adverse events were thrombocytopenia (52% vs 47%), neutropenia (49% vs 46%), nausea (48% vs 28%), peripheral neuropathy (47% vs 5%), diarrhea (46% vs 17%), anemia (43% vs 55%), constipation (37% vs 16%), neuralgia (36% vs 1%), leukopenia (33% vs 30%), and vomiting (33% vs 16%).

Relapsed MM and Mantle Cell Lymphoma (MCL): In the integrated analysis of 1163 patients in phase 2 and 3 studies of VELCADE (bortezomib) administered IV, the most commonly reported adverse events were asthenic conditions (including fatigue, malaise, and weakness) (64%), nausea (55%), diarrhea (52%), constipation (41%), peripheral neuropathy (including peripheral sensory neuropathy and peripheral neuropathy aggravated) (39%), thrombocytopenia and appetite decreased (including anorexia) (each 36%), pyrexia (34%), and vomiting (33%). A total of 50% of patients experienced serious adverse events (SAEs). The most commonly reported SAEs included pneumonia (7%); pyrexia (6%); diarrhea (5%); vomiting (4%); and nausea, dehydration, dyspnea, and thrombocytopenia (each 3%).

Relapsed MM Subcutaneous vs IV: In the phase 3 study of VELCADE (bortezomib) administered subcutaneously vs IV in relapsed MM, safety data were similar between the 2 treatment groups. The most commonly reported adverse events in this study were peripheral neuropathy (38% vs 53%), anemia (36% vs 35%), and thrombocytopenia (35% vs 36%). The incidence of SAEs was similar for the subcutaneous treatment group (36%) and the IV treatment group (35%). The most commonly reported SAEs were pneumonia (6%) and pyrexia (3%) in the subcutaneous treatment group and pneumonia (7%), diarrhea (4%), peripheral sensory neuropathy (3%), and renal failure (3%) in the IV treatment group.

Please click here for full Prescribing Information, also available at www.VELCADEHCP.com.

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